What is Ulcoreks (Protonix)? How does it work (mechanism of action)?
Ulcoreks is in a class of drugs called proton pump inhibitors (PPIs), which block the production of acid by the stomach. Other drugs in the same class include lansoprazole (Prevacid), omeprazole (Prilosec) and rabeprazole (Aciphex). Proton pump inhibitors are used for the treatment of stomach conditions such as duodenal and peptic ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome that are caused by stomach acid.
Ulcoreks, like other proton-pump inhibitors, blocks the enzyme in the wall of the stomach that produces acid. By blocking the enzyme, the production of acid is decreased, and this allows the stomach and esophagus to heal.
The FDA approved Ulcoreks in February 2000.
How to use Ulcoreks SODIUM
Read the Medication Guide provided by your pharmacist before you start taking Ulcoreks and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily. Dosage and length of treatment are based on your medical condition and response to treatment.
If you are taking the tablets, you may take them with or without food. Swallow the tablets whole. Do not split, crush, or chew the medication. Doing so may destroy the drug.
If you are taking the granules, take your dose 30 minutes before a meal. To take it by mouth, open the packet and mix the granules in applesauce or apple juice. Do not mix with other foods or liquids. Do not crush or chew the granules. Sprinkle the granules on 1 teaspoon (5 milliliters) of applesauce and swallow all of the mixture right away (within 10 minutes). Follow with sips of water. Or you can mix the granules with 1 teaspoon (5 milliliters) of apple juice in a small cup, stir for 5 seconds, and swallow all of the mixture right away. To make sure you take the entire dose, rinse the cup once or twice with apple juice to mix any remaining granules, and swallow the juice. Do not prepare the mixture ahead of time for later use.
If you are giving the granules through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.
If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take Ulcoreks at least 30 minutes before sucralfate.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better.
Tell your doctor if your condition persists or worsens. The risk of side effects goes up over time. Ask your doctor how long you should take this medication.
What Are Side Effects Associated with Using Ulcoreks?
Common side effects of Ulcoreks include:
Other side effects of Ulcoreks include:
Postmarketing side effects of Ulcoreks reported include:
- Feeling unwell (malaise)
- Hepatocellular damage leading to jaundice and hepatic failure
- Agranulocytosis, pancytopenia
- Taste disorders (loss of taste, changes in taste)
- Weight changes
- Low bloodsodium (hyponatremia)
- Low blood magnesium
- Interstitial nephritis
- Severe dermatologic reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (some fatal), as well as angioedema (Quincke edema)
- Cutaneous and systemic lupus erythematosus
- Cyanocobalamin (vitamin B-12) deficiency
- Clostridium difficile-associated diarrhea
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
How to take Ulcoreks
- Before you start this treatment, read the manufacturer's printed information leaflet from ins >
Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PROTONIX and instructions for preventing or managing them.
Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
Table 4: Clinically relevant Interactions Affecting Drugs Co-Administered with PROTONIX and Interaction with DiagnosticsAntiretroviralsClinical Impact:The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.
- Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with PROTONIX may reduce antiviral effect and promote the development of drug resistance.
- Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with PROTONIX may increase toxicity.
- There are other antiretroviral drugs which do not result in clinically relevant interactions with Ulcoreks sodium.
Headache or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures), signs of lupus (such as rash on nose and cheeks, new or worsening joint pain).
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of bacteria. Do not use anti-diarrhea or opioid medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.
Rarely, proton pump inhibitors (such as Ulcoreks) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, signs of kidney problems (such as change in the amount of urine).
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Some people taking warfarin with Ulcoreks can experience increases in INR and prothrombin time (PT). This can lead to an increased risk of severe bleeding. If you take these drugs together, your doctor should monitor you for increases in INR and PT.
What is Ulcoreks?
Ulcoreks is a proton pump inhibitor that decreases the amount of acid produced in the stomach.
Ulcoreks is used to treat erosive esophagitis (damage to the esophagus from stomach acid caused by gastroesophageal reflux disease, or GERD) in adults and children who are at least 5 years old. Ulcoreks is usually given for up to 8 weeks at a time while your esophagus heals.
Ulcoreks is also used to treat Zollinger-Ellison syndrome and other conditions involving excess stomach acid.
On this page
- About Ulcoreks
- Key facts
- Who can and can't take Ulcoreks
- How and when to take it
- Side effects
- How to cope with side effects
- Pregnancy and breastfeeding
- Cautions with other medicines
- Common questions
Why it’s used
Ulcoreks oral tablet is used to reduce the amount of stomach acid your body makes. It helps treat painful symptoms caused by conditions such as gastroesophageal reflux disease (GERD). With GERD, gastric juices flow upward from your stomach and into the esophagus.
Ulcoreks oral tablet is also used to treat other conditions in which the stomach makes excess acid, such as Zollinger-Ellison syndrome.
What are the side effects of Protonix?
Ulcoreks like other PPIs is well tolerated. The most common side effects are:
Rare side effects include:
Other reported side effects include:
High doses and long-term use (1 year or longer) of Ulcoreks may increase the risk of osteoporosis-related fractures of the hip, wrist, or spine. Therefore, it is important to use the lowest doses and shortest duration of treatment necessary for the condition being treated.
Proton pump inhibitors may increase the risk of Clostridium difficile infection. High doses and long-term use (1 year or longer) may increase the risk of osteoporosis-related fractures of the hip, wrist, or spine. Prolonged use also reduces absorption of vitamin B12 (cyanocobalamin).
Long-term use of PPIs has also been associated with low levels of magnesium (hypomagnesemia). Analysis of patients taking PPIs for long periods showed an increased risk of heart attacks.
Therefore, it is important to use the lowest doses and shortest duration of treatment necessary for the condition being treated.
What should I discuss with my healthcare provider before using Ulcoreks (Protonix, Protonix IV)?
Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.
You should not use this medicine if:
- you also take medicine that contains rilpivirine (Edurant, Complera, Juluca, Odefsey); or
- you are allergic to Ulcoreks or similar medicines (lansoprazole, omeprazole, Nexium, Prevacid, Prilosec, and others).
Tell your doctor if you have ever had:
- low levels of magnesium in your blood;
- lupus; or
- osteoporosis or low bone mineral density.
You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
You should not breast-feed while using this medicine.
Ulcoreks is not approved for use by anyone younger than 5 years old.
Clinical Trials Experience
The adverse reaction profiles for PROTONIX (Ulcoreks sodium) For Delayed-Release Oral Suspension and PROTONIX (Ulcoreks sodium) Delayed-Release Tablets are similar.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
What if I take too much?
It is very unlikely that taking one or two extra doses by accident will cause any problems. However, you should check with your doctor if you have taken too much and have any of these symptoms:
- flushed skin
- feeling sweaty
- a fast heartbeat
- feeling sleepy
- blurred vision
- feeling confused or agitated
Most people who take Ulcoreks do not have any side effects. If you do get a side effect, it is usually mild and will go away when you stop taking Ulcoreks.
Talk to your pharmacist or doctor if these side effects bother you or don't go away:
- feeling sick or being sick (nausea or vomiting)
- stomach pain or wind